AHA: Doctors Dispute 'Bad News' About Thiazolidinediones

By Ed Susman, Contributing Writer, MedPage TodayNovember 06, 2007
ORLANDO, Nov, 6 -- Media hysteria rather than hard science resulted in black box warnings on supposed dangers of thiazolidinediones for treatment of patients with diabetes, some doctors here suggested.
In an industry-sponsored symposium held in conjunction with the American Heart Association meeting, Burton Sobel, M.D., of the University of Vermont in Burlington, noted that the drugs -- specifically rosiglitazone (Avandia) and pioglitazone (Actos) -- have been at the center of a "maelstrom of controversy that has come about for whatever reason."
Particularly singled out for criticism was the recent meta-analysis authored by Steve Nissen, M.D., director of cardiology at the Cleveland Clinic (NEJM, May 21, 2007).
The validity of Dr. Nissen's findings was challenged by Silvio E. Inzucchi, M.D., clinical director of the Section of Endocrinology at Yale. "Any minor manipulations to this information can be done to show either how much harm rosiglitazone is doing, or how much good it has done," Dr. Inzucchi claimed.
He said that in the Nissen paper researchers "took results from small trials, calculated the odds and they came up with a 43% increase in myocardial infarction."
In a follow-up analysis, he said, researchers used the "faulty" Nissen data. "This is why they had a similar outcome," he said.
Dr. Inzucchi agreed there was some data that indicated rosiglitazone patients appeared to experience a "modest increase in heart failure." But, he said, the news accounts of these studies created an atmosphere that made it necessary for the Food and Drug Administration to require black box labeling for the drugs. "That label is an FDA reaction to the media hysteria surrounding thiazolidinediones," he said.
Another speaker at the symposium, sponsored by Takeda Pharmaceuticals, the developer of pioglitazone, William Chutkow, M.D., Ph.D., of Harvard and Brigham and Women's Hospital, reviewed data on drugs used in treatment of diabetes, including the thiazolidinediones. "[Thiazolidinediones] seem capable of improving all of the insults a diabetic patient would have to face," he said.
Although he discussed metformin, niacin, and other medications, Dr. Chutkow said, "there is still a lot of confusing data, even as late as the year 2007, out there about these drugs to figure out which amongst them is the 'safe' one."